Spironolactone

Product NDC
63629-2438
11-digit product format
636292438
Labeler code
63629
Product ID
63629-2438_dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203253
Marketing category
ANDA
Marketing start
2013-02-01
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
27O7W4T232SPIRONOLACTONE52-01-7SPIRONOLACTONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-2438-163629243801100 TABLET, FILM COATED in 1 BOTTLE (63629-2438-1) 2017-04-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SpironolactoneBryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL103